Associate Director, Regulatory Affairs

BioSpace; Toronto; On-site; CAD 150,000 - 190,000; Full time

Job summary

Moderna in Toronto seeks an experienced Regulatory Leader to shape the regulatory strategy for mRNA therapeutics in Canada. You will define regulatory strategy, lead critical submissions, and partner with global and local teams to accelerate medicines to patients.

You will also collaborate with cross-functional teams embracing digital innovation and AI to enhance regulatory excellence. Join a rapidly evolving environment where collaboration, accountability, and high-quality execution drive

Responsibilities

• Lead the planning, preparation, review, and execution of Health Canada regulatory submissions, including CTAs, NDSs, SNDSs, and post-Notices of Compliance submissions.

Job description

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its presence in Toronto, a leading biotech hub in Canada. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global talent ready to help transform medicine and improve lives.

This is an opportunity for an experienced regulatory leader to help shape the future of mRNA therapeutics in Canada. As part of a rapidly evolving environment, you will define regulatory strategy, lead critical submissions, and build strong partnerships across global and local teams to accelerate innovative medicines to patients. You'll also have the opportunity to work alongside cross-functional teams embracing digital innovation and emerging Generative AI tools to enhance regulatory excellence and decision-making.

Here’s What You'll Do

• Contribute to the success of the Canadian Regulatory Affairs team by fostering collaboration, alignment, accountability, and high-quality execution across multiple priorities and projects.
• Develop and influence Canadian regulatory strategy in close partnership with Global Regulatory Science and cross-functional stakeholders, ensuring Canadian regulatory requirements and business objectives are embedded within global development and commercialization plans.
• Lead the planning, preparation, review, and execution of Health Canada regulatory submissions, including Clinical Trial Applications (CTAs), New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Health Canada meeting requests, post-Notice of Compliance (NOC) submissions, amendments, and supplements.